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Bioterrorism Agent Compliance “Impact on Academia” Cheri Hildreth Watts, Director Department of Environmental Health & Safety University of Louisville
A Brave New World ? For EHS and Academic Professionals Dealing with Select Agents… n EHS role in the spotlight n Lots of new money for biodefense research -- $6 Billion project “Bioshield” ($1. 8 B NIAID) n “Bioterrorism becomes one of the hottest US research fields” Nature Medicine, March 2002 n FBI, DOJ, CDC, DHHS, UDSA officials on campuses across the country
Why? ? Let me count the ways… n Because we as ROs and other individuals could go to jail and face significant penalties i. e civil and criminal penalties for individuals and other persons up to maximum of $250, 000/$500, 000 respectively n Big looming questions regarding SA regulations so we’re left with interpretations while regulations are in a state of flux n “Open culture”, governance mechanisms and collaborative research will all be impediments in implementing compliance requirements
The Subpoena that Many *Universities Received… n Started in fall 2001 during anthrax letter investigation n EHS played key role along with University Counsel n Very time consuming lasting 2 -4 weeks n Some asked for records going back ten years n FBI interviewed PIs asking 40 -50 questions
_______________ “The Forces” n USA PATRIOT Act– October 26, 2001 n Public Health Security and Bioterrorism Preparedness and Security Act— June 12, 2002
USA PATRIOT vs. PHSBPRA n USA PATRIOT Act very broad only 1 ½ pages out of 342 on Select Agents (SA) – Section 817 n Covers “possession” of SA for first time n Establishes possession standards i. e. bona fide research or other peaceful purpose n Assurance that no “restricted persons” have access to SA but not prescriptive in how to accomplish n Some universities opted to do “self declaration” while others did actual background checks
PHSBPRA and 12/13 Regs n Includes a separate requirement for Attorney General’s Office (AGO) to do security risk assessment for RO, individuals that have access and any individual who owns or controls the entity n Restricted person definition is retained n Process and mechanism not yet known n Deadlines in March and April to submit information to AGO– RO and entity before individuals with access! n Doesn’t eliminate need to comply with checks for “restricted persons” with access to SA under PATRIOT Act
Memory Lane: Issues that Came Up Some Not Resolved…. n 9/10 federally mandated notification to help agency prepare for promulgation of 12/13 SA regs– just the beginning n Multiple forms and single geographical location issue n Isolates from naturally occurring sources n Medical use exemption versus “off-label” uses not extensively surveyed
Academic Researchers and Faculty in the News…. n 6/19/02 - 2 Harvard researchers arrested for allegedly stealing biological materials and scientific documents n 7/16/02 - Brown University former Ph. D student accused of stealing biological materials and data n 7/28/02 - Cornell post-doc stopped at airport with vials of biological agents in luggage and daughter’s backpack in route to China “Because we are a university community, we don’t want to adversely affect university openness with draconian measures. But of course, security is a priority. ” University response
UConn Grad Student Plea Agreement 7/22/02 Charged: ”Tomas Foral says the case resulted from a misunderstanding. ” Science Magazine 8/2/02
Details and Impact of UConn Student Plea Agreement n Grad student’s work was on West Nile virus n Malfunctioning basement freezer in Pathobiology Department found to have anthrax samples from cow necropsy done in 1960’s n Grad student allegedly told by lab supervisor to “get rid” of 7 vials of anthrax– he keeps two for potential future work n Occurred sometime between October 27 - November 27, 2001 during the height of national anthrax investigation
Continued Details on UConn Student Plea Agreement n November 21, 2001 a 94 year old Connecticut woman dies of inhalational anthrax n Whistleblower reports Tomas Foral’s possession of two vials of anthrax n FBI and other law enforcement officials descend on campus and shut down lab building for one week n Must perform 96 hours of community service and on probation for 6 months– Foral said he couldn’t afford to fight the charges n Basis of charge was DOJ’s contention that he did not possess the anthrax for “bona fide” research
LSU Defends Firing Steven Hatfill 9/3/02 n One of several people interviewed by FBI in fall 2001 anthrax investigation n Dismissed by LSU after DOJ identifies Hatfill as “person of interest”
Texas Tech Professor Arrested 1/16/03 T T e Accused: “Plague specialist Thomas Butler is arrested for lying about the whereabouts of samples of plague bacteria. ” Science Magazine
Details of Texas Tech Arrest n 1/16/03 Dr. Butler arrested for false information to FBI on whereabouts of ~ 30 slides/vials of Yersinia pestis aka “plague” n Per public information accounts, Dr. Butler knew this was incorrect and that in fact they had already been mistakenly destroyed—later recanted statements n University officials notified law enforcement and public health officials around 3: 30 pm on 1/14
Continued Details of Texas Tech Arrest n By 8: 00 pm on 1/14 over 60 federal, state and local law enforcement officials including DOJ and CDC were on campus conducting the investigation n Butler repeated false statement to FBI and later recanted on 1/15 when investigation was called off n n Arrested 1/16 and remained jailed until release on 1/21 after posting $100, 000 bail and is being required to wear an electronic monitoring anklet Federal decision on indictment before end of February
The New Regulatory Environment n Individuals are now vulnerable to consequences of enforcement as opposed to enforcement traditionally limited to the institution n Researchers and administrators are going to have to take Select Agents (SA) rules much more seriously than anything before including human subject research n Tension between decision to get out of SA business to avoid regulation and jumping in because of the proliferation of grant money n EHS in pivotal role to help raise awareness in academic community and design compliance mechanisms
Culture Clash n Arrests of Asian scientists for alleged thefts of research materials and documents -- profiling? per 10/18/02 Chronicle article at least a quarter of the cases filed under the Economic Espionage Act of 1996 have been against Asian defendants n Foreign professors and lab staff under more scrutiny than most counterparts due to “restricted persons” definition—clash between implementing the regs and institutional policies on discrimination n Clash between traditionally “open” campus environment and the need for security and restricted access n Infringement of personal and academic freedoms are potentially counterproductive to the advancement of science
Trend Towards Destruction of SA n Onerous requirements have led to many investigators to decide to get out of SA work and have requested destruction of SA n OSTP (Office of Science and Technology Policy) in White House has recently pushed for the creation of a SA repository due to concern about need for SA for future research – too little too late? ? n Sites still being considered by feds but regulations are in state of flux so no transfers likely any time soon Recent list serve discussion about arctic ice samples –research vs. regulation
Surge in New Grant Monies for Biodefense Research n President Bush announced $6 Billion in funding available for “Project Bioshield”-- $1. 8 B of this in NIAID n Some universities are making the decision to submit proposals for this money despite the fact that they have little or no experience with BSL 3 or 4 agents or facilities n Others deciding not to because regs are too confusing, bureaucratic and expensive n More biosafety experts will be needed
SA Compliance an “Unfunded Mandate” n New regulation will require significant improvements in security n NIH response -- cover lab infrastructure improvements out of indirect costs n Make informed decision about current or future SA research since reallocation of resources might be necessary n Need for “early warning” mechanism of new research recruits that might work with SA– 9/10 notification was just a “picture in time”
SA Regulations in a State of Flux n Regulations effective 2/7/03 but comment period open until 2/11/03 so what’s in place now may change n ASM, ABSA, COGR, AAU, ACE, HHMI, AAMC and many universities have submitted comments to date n Significant questions surrounding definition of packages, area, access, timetable for researchers after 2/7 n Registration and security clearance applications still not available but deadlines are approaching n List of SA to be reviewed biennially Lipah virus only discovered in 1999
SA State of Flux What’s an RO to do? When will we know what we’re supposed to do. . I don’t want to go to jail n Responsible officials will have to be constantly vigilant in watching for changes in the regulations n ROs and others should read SA regulation comments and become familiar with outstanding issues for universities n Monitoring and implementation of regulations will be time consuming and costly so … communicate with administrators
Off-label Use Issue n Section 73. 6 (b)– the “medical use” exemption n Currently, only exempt provided their use “is only for the approved purpose” n The Bo. Tox example– FDA approved uses are: - blepharospasm ( eye disorder), 1989 - strabismus ( eye disorder), 1989 - cervical dystonia ( neuromuscular), 2000 - frown lines ( cosmetic), 2002 n Bo. Tox used commonly in a couple of gastrointestinal disorders – legal for physicians to do this but technically it is not approved by FDA for this use n Comments are being submitted on this issue by COGR and AAMC
Raising Awareness of SA Compliance on Campus n Stakes are high so there is a need to go beyond traditional means of communication n Governance mechanisms make this a challenge in academic setting n Expanding the forums you address on this issue– research deans, research advisory council, research integrity task force meetings executive council/president and VPs, relevant deans staff meetings, relevant department chair meetings n Power. Point presentations, briefing documents, web sites, newsletters, informational bulletins n Using UConn and Texas Tech arrests as way to get institution’s attention?
New Policies and Procedures n Can’t have governance by folkfore therefore written policies are needed n Universities are developing policies to cover destruction and acquisition of SA, lab commissioning and decommissioning n Anyone trying to tackle a policy on possession for legitimate scientific purpose aka UConn grad student plea agreement n Policy and procedure for true inventory vs. declaration of SA --which one, frequency, how broad of a list of materials of concern i. e. more biologicals, chemical precursors, radioactive materials?
Use of New or Existing Committees n Institutional Biosafety Committee and its changing role n USA PATRIOT Act and PHSBPRA compliance task forces n Laboratory security and accountability task groups n Looking for gaps and recommending new processes n Getting representation from all relevant areas
EHS Relationships n Relationship between EHS and researchers n Relationship between EHS and campus police/security n Relationship between EHS and senior campus administration/ management n Ability of EHS to stay on top of our “traditional” programs while implementing new bioterrorism agent compliance requirements
Security of Compliance and Scientific Information n EHS information and databases on SA– what measures if any are being taken now? n Security of scientific information vs. traditional openness n Recent NAS decision to censor sensitive information from a report on agricultural bioterrorism n ASM has developed its position and policies on this issue
Photos credited to…
Additional slides from Dr. Ron Atlas’s presentation at National ACHMM conference in Louisville, Ky. October 2, 20002 NOTE: Dr. Atlas is President of the American Society of Microbiology. He is also Graduate Dean, Professor of Biology, and Professor of Public Health, and Co-Director Center for Deterrence of Biowarfare and Bioterrorism at the University of Louisville.
Suggested Policy Mechanisms to Reduce Future Biological Weapons Threats – Tighten restrictions on access to dangerous pathogens – Impose restrictions on the conduct and publication of “contentious research, ” i. e. fundamental biological or biomedical investigations that produce organisms or knowledge that could have immediate weapons implications – Restrict access and dissemination of “relevant information” Controlling Biological Warfare Threats: Resolving Potential Tensions Among the Research Community, Industry, and the National Security Community. Gerald L. Epstein. Critical Reviews in Microbiology, 27 (2001)
– Even at the height of the Cold War era it was recognized that “greater security would be achieved by the open pursuit of scientific knowledge than by curtailing the free exchange of scientific information. ” » National Academy of Sciences 1982 Corson Report – “It is the policy of this Administration that, to the maximum extent possible, the products of fundamental research remain unrestricted. It is also the policy of this Administration that, where the national security requires control, the mechanism for control of information generated during federally-funded fundamental research in science, technology and engineering at colleges, universities and laboratories is classification. ” » National Security Decision Directive #189. National Policy on the Transfer of Scientific, Technical and Engineering Information. September 21, 1985.
ASM Opinion on Secrecy – “Terrorism feeds on fear, and fear feeds on ignorance. The best defense against anthrax or any other infectious disease is information – information in a form that can be used by scientists and by members of the public to guide rational and effective actions to ensure public safety. Placing major new barriers in the path of the flow of information between scientists and the public is more likely to contribute to terrorism than to prevent it. ” Abigail Salyers, Past President American Society for Microbiology
• The US is trying to balance openness with national security concerns but is struggling with how to achieve the right balance. • “The key to maintaining U. S. technological preeminence is to encourage open and collaborative basic research. The linkage between the free exchange of ideas and scientific innovation, prosperity, and U. S. national security is undeniable…the policy on the transfer of scientific, technical, and engineering information set forth in NSDD-189 shall remain in effect, and we will ensure that this policy is followed. ” – Condoleezza Rice, Special Assistant to President Bush for National Security Affairs affirmed the importance of openness of fundamental research in a letter of November, 2001
• Federal departments and agencies ordered to take steps to protect information regarding weapons of mass destruction as well as other information that could compromise national security – Memorandum from Andrew H. Card, Jr. , Assistant to the President and Chief of Staff, for the heads of executive departments. March 19, 2002. • Departments ordered to take steps to protect sensitive but unclassified information that might reasonably be expected to assist in the development or use of weapons of mass destruction. – Memorandum from Laura Kimberly, Acting Director Information Security Oversight Office, National Archives and Records Administration, and Richard Huff and Daniel Metcalfe, Co-directors of Information and Privacy, Department of Justice. March 19, 2002.
– Concern about sensitive biological information and the threat of recombinant DNA technology was sparked by the publication of experiments in which IL-4 genes were inserted into mousepox viruses, resulting in near total suppression of the immune response. » Jackson RJ. et al. 2001. Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. J. Virology 75: 1205 -10. – The IL-4 mousepox study was done in Australia, beyond the reach of US government regulations. » It was, however, potentially subject to restraint, raising the question of ethical responsibility within the scientific community.
• Report demonstrating that artificially synthesized polio virus genome produced infective pathogenic virus – Cello, J. , A. V. Paul, and E. Wimmer. 2002. Chemical synthesis of poliovirus c. DNA: Generation of infectious virus in the absence of natural template. Science express. July 2002/ Page 1/ 10. 1126/science. 1072266. • Executive Branch called upon to “…examine all policies, including national security directives, relevant to the classification or publication of federally funded research to ensure that, although the free exchange of information is encouraged, information that could be useful in the development of chemical, biological, or nuclear weapons is not made accessible to terrorists or countries of proliferation concern. ” - House Resolution 514. Introduced by Congressman Dave Weldon (R-Fla. ) and seven others on July 26, 2002
• Problem is that there is no clear definition of what constitutes "sensitive information" in the Life Sciences. • “the concept [of sensitive but unclassified information] is so squishy [ill defined] and fraught with danger that the only sensible thing for the research community to do is to demand [classification]. ” – William Wulf, President of the National Academy of Engineering, Leo, A. 2002. Science and secrets. Technology Review, June 20. • Many academic institutions, like MIT, reject classified research. A recent report recommended that MIT ban classified research on its main campus to protect its educational mission although faculty could conduct such research on MITs Lincoln campus. – In the Public Interest. Report of the ad hoc faculty committee on access to and disclosure of scientific information. Massachusetts Institute of Technology, June 12, 2002